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PAJUNK GmbH Medizintechnologie

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
44
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243690SonoMSKJuly 1, 2025
K243682SonoPlex STIM; SonoPlex IIJune 27, 2025
K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureJune 25, 2025
K243525SonoTAP and SonoTAP IIMarch 24, 2025
K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyNovember 22, 2024
K241954SonoBlock; SonoBlock IISeptember 11, 2024
K230701Stim2GoNovember 24, 2023
K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0February 22, 2023
K220897Disposable Brain Biopsy Needle 2.0August 17, 2022
K202699E-Cath STIM acc. TsuiDecember 29, 2020
K190663Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6June 17, 2019
K190345VPCMay 16, 2019
K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7May 3, 2018
K170305Spinal Manometer NRFit; Spinal Manometer LUERJuly 25, 2017
K170435NerveGuard NRFit, NerveGuard LUERJuly 12, 2017
K162086MultiStim ECOJanuary 6, 2017
K160297Tuohy NRFitOctober 28, 2016
K160296SPROTTE SPECIAL NRFitOctober 27, 2016
K160295SPROTTE NRFit, Quincke NRFitOctober 27, 2016
K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesOctober 21, 2016